Fused loop of filamentous material and apparatus for making same

ABSTRACT

A fused loop of an elongated material, such as a surgical suture, and apparatus for making the loop. Portions of one or more segments to be joined together are fused in a welding process to form a welded joint. The shear area of the fused portion of the joint determines the strength of the joint and is thus preferably relatively large. Various configurations for the welding apparatus facilitate the creation of relatively large fused portions of the joint by maximizing contact between at least one of the welding members of the apparatus and at least one of the segments to be joined.

FIELD OF THE INVENTION

The invention relates to improvements in sutures and suturingtechniques, and more particularly to materials and devices for makinghigh-strength fused suture loops during surgical procedures.

BACKGROUND OF THE INVENTION

In surgical procedures, a monofilamentous suture is typically used tostitch or secure the edges of tissue together to maintain them inproximity until healing is substantially completed. The suture isgenerally directed through the portions of the tissue to be joined andformed into a single loop or stitch, which is then knotted or otherwisesecured in order to maintain the wound edges in the appropriaterelationship to each other for healing to occur. In this manner a seriesof stitches of substantially uniform tension can be made in tissue.Because the stitches are individual and separate, the removal of onestitch does not require removal of them all or cause the remainingstitches to loosen. However, each individual stitch requires anindividual knot or some other stitch-closing device for securing thestitch around the wound.

It is sometimes necessary or desirable to close a wound site withsutures without having to form knots or incorporate loop-closing devicesin the sutures, such as, for example, in surgical repair of delicateorgans or tissues, where the repair site is relatively small orrestricted A fused suture loop must provide the appropriate tension onthe wound edges and the appropriate strength to maintain the wound edgesin sufficient proximity for a sufficient time to allow healing to occur.

Polymer sutures are particularly amenable to various fusing or joiningprocesses, such as, for example, welding, whereby sections of thesutures can be fused together upon application of sufficient heat to thesections to cause partial melting and fusion of the sections. Becausethe direct application of heat to sutures in situ may produceundesirable heating of the surrounding tissue, it is preferred to applynon-thermal energy to the suture material in situ to induce localizedheating of the suture material in the areas or sections to be fused. Inparticular, ultrasonic energy may be effectively applied to sections ofsuture materials to induce frictional heating of the sections in orderto fuse or weld them together.

While sutures typically fail under tensile loads applied along theprincipal axis of the suture, suture welds often fail in shear, i.e., inthe plane of the fused region between the overlapped segments of suturematerial. It is desirable to have the failure strength of the suturejoint be at least as great as the failure strength of the suturematerial away from the joint.

U.S. Pat. No. 5,417,700 to Egan and U.S. Pat. No. 3,515,848 to Winstonet al. disclose apparatus and methods for ultrasonic welding of sutures.The Winston et al. patent discloses, for example, the application ofmechanical energy to a segment of material to be joined in either of twodifferent directions. For joining plastic suture materials, mechanicalenergy is applied in a direction substantially parallel to the axis ofthe segments to be joined. For joining metallic suture materials,mechanical energy is applied in a direction substantially normal to thisaxis. The Winston et al. patent further discloses the use of a sphericalwelding tip for use in joining metallic suture materials.

Although ultrasonic welding of sutures is known, it has heretofore beendifficult or impossible to control the suture welding process in orderto produce suture welds of sufficient strength and reliability toreplace, or enhance the strength of, suture knots or other loop closuredevices.

It is therefore an object of the present invention to overcome thedisadvantages inherent in prior art suture loop joints and joiningprocesses.

SUMMARY OF THE INVENTION

The present invention provides a fused loop of an elongated material,such as a polymeric or monofilamentous suture material, which has astrength in the joint region which is at least equal to, if not greaterthan, the strength of the parent material. The present invention alsoprovides means for controlling the size and shape of the fused portionof the joint region in order to maximize joint strength.

According to one aspect of the invention, there is provided a fused loopof an elongated material comprising one or more segments of the materialwhich extends along a principal axis. Portions of the segments arejoined together to form a loop at a joint region which extends betweenfirst and second ends. The joint region includes a first portion ofelongated material extending from the first end, a second portion ofelongated material extending from the second end, and a fused portion orlayer between and joining the first and second portions at pointsbetween the first and second ends of the joint region. The fused portionpreferably comprises a relatively thin layer of fused material from thefirst and second portions.

The term “fused”, as used herein, refers to material which has beenheated to a plastic or fluid state and subsequently allowed to cool, sothat the relatively highly-oriented molecular structure of the parentmaterial is transformed into a relatively randomly-oriented molecularstructure characterizing the fused portion of the joint region. The term“shear area”, as used herein, refers to the area of the fused portionbetween and substantially parallel to the segments of material joined inthe joint region. In contrast, the cross-sectional area of the segmentsor the fused portion refers to the area in a plane substantiallytransverse to the principal axis of the segments.

The elongated material in the first and second portions of the jointregion is characterized by a relatively high degree of molecularorientation in the direction of the principal axis of the material, andthus relatively high strength in the direction of the principal axis.The fused material in the fused portion of the joint region ischaracterized by a relatively random molecular orientation, and thusrelatively low strength in the direction of the principal axis of thematerial. The cross-sectional area of the first and second portions ofthe segment at the first and second ends of the joint region, yetoutside of (i.e., not abutting) the fused portion, is greater than thecross-sectional area of the first and second portions of the jointregion which abut the fused portion.

In one embodiment, the cross-sectional area of the first and secondportions of the segment at the first and second ends of the jointregion, yet outside of the fused portion, is approximately equal to thecross-sectional area of a segment of the elongated material outside ofthe joint region.

In a preferred embodiment, the total cross-sectional area of the firstand second portions of the joint region which abut the fused portion isa minimum at approximately the midpoint of the fused portion. In a morepreferred embodiment, the total cross-sectional area of the first andsecond portions of the segment at the midpoint of the fused portion isapproximately half the total cross-sectional area of the first andsecond portions at the first and second ends of the joint region andoutside of, or not abutting, the fused portion. In an especiallypreferred embodiment, the change in cross-sectional area of the firstand second portions of the segment, per unit length of those portions,is substantially constant over the length of the fused portion of thejoint region.

The elongated material may comprise a substantially monofilamentousmaterial, such as, for example, a polymer. In a preferred embodiment,the elongated material is a thermoplastic polymer, such as a surgicalsuture material.

The segments of elongated material are preferably joined in a weld atthe joint region. The weld can be effected with various types of energy,such as, for example, ultrasonic, laser, electrical arc discharge, andthermal energy.

The loop of elongated material can be made by joining portions of asingle segment of the elongated material. Alternatively, the loop can bemade by joining portions of multiple segments of the material.

The elongated material itself can comprise a single strand of asubstantially monofilamentous material. Alternatively, the elongatedmaterial can comprise multiple strands of a substantiallymonofilamentous material which can be twisted, braided or otherwiseinterlinked.

Upon application of a tensile force to the joint region in the directionof the principal axis of the material, the first and second portions ofthe joint region are loaded substantially in tension, and the fusedportion of the joint region is loaded substantially in shear. In apreferred embodiment, the following equation,A_(w)τ_(fw)≧A_(u)σ_(fu),is preferably substantially satisfied. A_(w) is the shear area of thefused portion, τ_(fw) is the shear stress to failure of the fusedportion, A_(u) is the total cross-sectional area of the first and secondportions near the first and second ends of the joint region and outsideof (not abutting) the fused portion, and σ_(fu) is the tensile stress tofailure of the first and second portions near the first and second endsand outside of (not abutting) the fused portion.

According to another aspect of the invention, there is provided anultrasonic welding apparatus which includes a first member having afirst suture-contacting surface, a second member having a secondsuture-contacting surface, and means for moving the first memberrelative to the second member to define a gap between the respectivesuture-contacting surfaces. The first member is capable of vibrating anddelivering mechanical energy at ultrasonic frequencies. The secondmember is stationary relative to the first member. A fixture element isadapted to receive and maintain two or more segments of a material to bewelded in a predetermined alignment in the gap between the first andsecond surfaces of the first and second members during a weldingoperation. The contour of at least the first surface substantiallycorresponds to the contour of a segment of the material to be welded soas to promote acoustic coupling therebetween and establish substantiallycontinuous contact between the first surface and the segment over thelength of the first surface.

In one embodiment, one of the first and second surfaces is substantiallyconvex and the other of the surfaces is substantially concave. Inanother embodiment, one of the first and second surfaces issubstantially convex or substantially concave, and the other of thesurfaces is substantially flat. In yet another embodiment, both of thefirst and second surfaces are substantially convex. In still anotherembodiment, both of the surfaces are substantially flat.

The radius of curvature of the convex suture-contacting surface ispreferably not greater than the radius of curvature of the concavesuture-contacting surface. In the case in which both the first andsecond members have convex suture-contacting surfaces, the respectiveradii of curvature of the convex surfaces can be different, or they canbe substantially identical.

In another embodiment, the second member comprises a plurality ofcoupling portions which couple together to form the second surfaceduring a welding process and separate after completion of the weldingprocess to release the loop.

According to another aspect of the invention, an ultrasonic weldingapparatus as described above includes first and second members withpatterned first and second suture-contacting surfaces. The patternedsurfaces can be complementary or non-complementary, and the surfacepatterns on each member may vary in either a periodic or an aperiodicmanner.

These and other features of the invention will be more fully appreciatedwith reference to the following detailed description which is to be readin conjunction with the attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is further described by the following description andfigures, in which:

FIG. 1 is a perspective view of a fused loop of an elongated material;

FIG. 2A is an axial view of the fused loop of FIG. 1;

FIG. 2B is an axial view of several fused loops formed by joiningmultiple segments of material together;

FIG. 2C is a simplified perspective view of a multiple-stranded segmentof elongated material;

FIG. 3 is a cross-sectional view of the joint region of the fused loopof FIG. 2A, taken along section lines A-A;

FIG. 4 is a cross-sectional view of the joint region of the fused loopof FIG. 2A, taken along section lines B-B;

FIG. 5 is a cross-sectional view of an end of the joint region of thefused loop of FIG. 2A, taken along section lines C-C;

FIG. 6 is a cross-sectional view of a segment of elongated material inthe fused loop of FIG. 2A, taken along section lines D-D;

FIG. 7A is a side elevational view of a joint region of a fused loopmade by ultrasonic welding;

FIG. 7B is a series of sectional views of a portion of the joint regionof the loop shown in FIG. 7A;

FIG. 8A is a side elevational view of a joint region of a different typeof fused loop made by laser welding or controlled coupling ultrasonicwelding;

FIG. 8B is a series of sectional views of a portion of the joint regionof the loop shown in FIG. 8A;

FIG. 9A is an axial view of a fused loop loaded in tension, in which thestrength of the joint region exceeds the tensile failure strength of theelongated material;

FIG. 9B is an axial view of a fused loop loaded in tension, in which thestrength of the joint region is less than the tensile failure strengthof the elongated material;

FIGS. 10A, 11A, 12A, 13A and 14A are exploded perspective views ofultrasonic welding members of various geometries, and segments ofmaterial to be welded in the gaps between their respective surfaces;

FIGS. 10B, 11B, 12B, 13B and 14B are exploded side elevational viewscorresponding to the views of FIGS. 10A, 11A, 12A, 13A and 14A;

FIGS. 15A, 16 and 17A are side elevational views of ultrasonic weldingmembers of various geometries engaged about a pair of segments ofmaterial to be welded;

FIG. 15B is a simplified side elevational view of the second weldingmember of FIG. 15A, uncoupled to show means for releasing the weldedloop from the welding apparatus;

FIG. 17B is a side elevational view of the second welding member of FIG.17A, uncoupled to show means for releasing the welded loop from thewelding apparatus;

FIG. 18 is an exploded perspective view of a segment of an elongatedmaterial with its ends aligned within an ultrasonic welding apparatusdesigned to produce a contoured lap weld;

FIG. 19A is an axial view of the segments of material within theultrasonic welding apparatus of FIG. 18, prior to welding;

FIG. 19B is an axial view of the segments of material within theultrasonic welding apparatus of FIG. 18, immediately after the weldingprocess and prior to release of the loop;

FIG. 20 is an enlarged perspective view of the fused suture sections ofa fused loop, showing the effect of a textured or waffledsuture-contacting surface on the welding horn;

FIG. 21 is a cross-sectional view of the fused region of FIG. 20;

FIG. 22 is a side view of a fused loop having a fused regioncharacterized by a complementary waffled pattern on the suture-contacingsurfaces of the welding horn and anvil;

FIG. 23 is a side view of a welding horn and anvil with complementarywaffled or textured suture-contacting surfaces;

FIG. 24 is a side view of the fused region of a portion of a fused loop,in which the loop and fused region are in a relatively relaxed state andthe loop has a nominal diameter; and

FIG. 25 is a side view of a fused region of a portion of a fused loop,in which the loop and fused region are under tension and the loop has anextended diameter as a result of the expansion of the waffled jointregion.

Like elements in the respective FIGURES have the same reference numbers.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides a fused loop of an elongated material,such as a surgical suture. The loop has at least comparable strength toknotted loops or loops closed by other means by virtue of the propertiesof the fused portion of the joint region of the loop, as detailed morefully below.

As shown in FIG. 1, the fused loop 10 of the present invention comprisesone or more segments 12 of an elongated material, such as a surgicalsuture material or other substantially monofilamentous material, whichis amenable to bonding through the application of heat or energythereto. Suitable materials for the elongated material include polymers,especially thermoplastic materials such as, for example, nylon(polyamide), polypropylene, Dacron® (polyester), polyglycolic acid(PGA), polyglyconate, and polydioxanone.

The fused loop of the present invention is preferably formed through awelding process, in which segments of the material to be joined arelocally heated through the application of energy thereto until thesegments fuse together. Various types of welded joints can be formed bythe application of, for example, ultrasonic, thermal, laser, electricalarc discharge, or thermal energy to the segments, which can be joined,for example, in an overlapped joint.

FIG. 2A is an axial view of the fused loop shown in FIG. 1. The segment12 of elongated material extends along a principal axis X of thematerial, which can be straight or curved. One or more segments 12 ofthe material are typically formed into a loop by, for example,overlapping portions of the respective ends 12A, 12B of the segment, asshown in FIGS. 1 and 2A, to form a joint region 14. Alternatively, asshown in FIG. 2B, both terminal and nonterminal portions of the segmentsof the material can be overlapped to form several fused loops joined ina single joint region 14.

The segments may already be knotted in preparation for fusion bywelding, or they may simply be overlapped.

The elongated material can be made of a single strand of a substantiallymonofilamentous material, or it can comprise multiple strands, asindicated in FIG. 2C. The multi-stranded material can be twisted,braided or otherwise interlinked to increase the density, and thus thestrength, of the composite strand.

The joint region 14 extends between first and second ends 14A, 14B andincludes a first portion 16 of elongated material extending from thefirst end 14A, and a second portion 18 extending from the second end14B. The joint region 14 further includes a fused portion 20 which has asubstantially uniform thickness and which is disposed between the firstportion 16 and second portion 18 of the joint region. The fused portion20 is made of material from the first and second portions 16, 18 whichhas been fused together. In a preferred embodiment, all of the fusedmaterial is disposed within a fused layer or portion 20. However, someof the melted and fused material may be extruded outside of the fusedportion 20 as a result of forces applied to the segments 16, 18 tocompress them together during the welding process.

As mentioned previously, the elongated material of the type used insurgical sutures is substantially monofilamentous, and preferablypolymeric. Because the molecular structure of monofilamentous materialsis highly oriented along the principal axis of the material, thematerial exhibits relatively high strength in the direction of itsprincipal axis. The elongated material in the loop segment outside thejoint region 14, as well as in the first and second portions 16, 18 ofthe joint region, is characterized by a relatively high degree ofmolecular orientation in the direction of the principal axis X of thematerial. As a consequence of this highly oriented molecular structure,the strength of the elongated material outside the joint region, and inthe first and second portions 16, 18 of the joint region, is alsorelatively great in the direction of the principal axis X. On the otherhand, the material which makes up the fused portion 20 of the jointregion 14 is characterized by a relatively random molecular orientation,by virtue of its having been heated locally to a plastic state by theapplication of energy, such as ultrasonic energy, to the segmentportions 16, 18 which make up the joint region 14. As a consequence ofthis relatively nonoriented molecular structure, the strength of thematerial in the fused portion 20 of the joint region may be relativelylow in the direction of the principal axis.

The shear area of the fused portion 20 is approximately defined as theproduct of the length L and the width W of the fused portion 20, asshown in FIG. 4. As will be detailed more fully below, for maximum jointstrength, it is desirable to have a relatively large shear area of thefused portion 20 of the joint region.

FIG. 6 indicates the cross-sectional area of a typical segment ofelongated material outside the joint region. Although the elongatedmaterial can be a strand or filament having a substantially circularcross-section, the invention is not limited to such geometries and caninclude elongated materials having eccentric or other cross-sectionalgeometries, such as, for example, relatively flat ribbons havingelliptical or rectangular cross-sections, or others. FIG. 5 indicatesthe cross-sectional area of the elongated material at the ends of thejoint region, outside of the fused portion 20. As can be seen in FIG. 3,7 and 8, the total cross-sectional area of the portions 16, 18 abuttingthe fused portion 20 of the joint region 14 is somewhat less than thetotal cross-sectional area of the first and second portions 16, 18 inthe joint region but outside of, and not abutting, the fused portion 20.As is clearly shown in FIGS. 2A and 3, some of the elongated material inportions 16 and 18 of the joint region is transformed during the weldingprocess from an elongated, relatively highly oriented material, to afused, relatively randomly-oriented material in the fused portion 20.Controlled compression of the portions 16, 18 during the welding processensures that the fused portion 20 has a relatively large shear area anda relatively small thickness.

The change in cross-sectional area of the overlapping segments 16, 18 inthe joint region is preferably uniform and gradual over the length ofthe fused portion 20. FIGS. 7A, 7B, 8A and 8B illustrate the change incross-sectional area of the overlapping segments of elongated materialin the joint region 14 throughout the length of the fused portion 20 fordifferent types of welded joints. At the ends 14A, 14B of the jointregion, outside of or beyond the fused portion 20, the cross-sectionalarea of the segment portions 16, 18 is a maximum value, as the segmentportions have not been caused to deform plastically at these points. Asthe cross-hatched areas 21 a-21 e in the joint region 14 indicate inFIG. 7B, the cross-sectional area of each of the overlapped segmentportions 16, 18 decreases gradually from a maximum value at the ends ofthe fused portion 20 to a minimum value at or near the midpoint of thefused portion. Preferably, at the midpoint of the fused portion 20, thetotal cross-sectional area of the segments 16, 18 not sacrificed to formthe fused portion is approximately half the total cross-sectional areaof the segments 16, 18 at the first and second ends 14A, 14B of thejoint region and beyond, or outside of, the fused portion 20.

The lap welded joint shown in FIG. 8A is preferably characterized by acontinuously varying cross-sectional area of the segments 16 and 18 inthe region of the fused portion 20. As indicated in FIG. 8B, thecross-sectional area 21 a-21 e of one segment 16 continuously decreasesfrom a maximum value at end 14B to a minimum value at the opposite end14A, whereas the cross-sectional area of the other segment 18continuously increases from a minimum value at end 14B to a maximumvalue at the opposite end 14A. At approximately the midpoint of thefused portion 20, the cross-sectional areas of the segment portions 16,18 are preferably approximately equal to each other and are preferablyequal to about half the total cross-sectional areas of the segmentportions 16, 18 at the first and second ends 14A, 14B of the jointregion and outside the fused portion 20.

Other geometries of the first and second portions 16, 18 in the jointregion 14 which provide a uniform change in cross-sectional area of thejoined segments in the joint region are also considered to be within thescope of the invention.

In a preferred embodiment of the invention, the shear area of the fusedportion 20 of the joint region is sufficiently large to ensure that thejoint will not fail prematurely, i.e., before the parent elongatedmaterial fails. The joint preferably has a failure strength at least asgreat as the strength of the parent material. Most preferably, the jointhas a failure strength in shear which is greater than or equal to thefailure strength in tension of the parent material.

Upon application of a tensile force to the joint region 14 in thedirection of the principal axis X of the material, the first and secondportions 16, 18 of the joint region are loaded substantially in tensionand the fused portion 20 of the joint region is loaded substantially inshear. In this situation, the following equation,A_(w)τ_(fw)≧A_(u)σ_(fu),is substantially satisfied, wherein A_(w) is the shear area of the fusedportion 20 (i.e., the area of the layer of the fused portion which isbetween the first and second portions 16, 18, not the cross-sectionalarea of this layer), τ_(fw) is the shear stress to failure of the fusedportion, A_(u) is the total cross-sectional area of the first and secondportions 16, 18 near the first and second ends of the joint region 14,outside of and not abutting the fused portion, and σ_(fu) is the tensilestress to failure of the first and second portions near the first andsecond ends, outside of and not abutting the fused portion.

If the above equation is not satisfied, the strength of the fusedportion 20 may only be approximately equal to, and possibly less than,the strength of the parent material. It is of course preferred that thefused portion 20 be at least as strong as the unfused parent material.If it is stronger, when the joint is loaded in tension, as indicated byforce arrows F in FIGS. 9A and 9B, the material will fail in tensilemode, and the loop will break at a point which is outside the fusedportion, and possibly outside the joint region, as indicated in FIG. 9A.If the fused portion 20 is weaker than the parent material, the fusedmaterial within the joint will fail in shear mode, and the loop willseparate at the fused portion, as indicated in FIG. 9B.

FIGS. 10A-14B illustrate various geometries for ultrasonic weldingapparatus, and more particularly for the vibratory and stationarymembers of an ultrasonic welding tip, which includes a first member 30and a second member 32. The first member 30 is capable of vibrating anddelivering mechanical energy at ultrasonic frequencies, as is known inthe art. The first member 30 is movable relative to the second member32, so that a gap or space can be defined between the first and secondmembers. The gap is sufficiently large to accommodate two or moresegments 16, 18 of material to be joined together. The ultrasonicwelding apparatus further includes a fixture element for aligning andmaintaining the segments 16, 18 in a predetermined alignment andorientation prior to and during the welding process.

The first and second members 30, 32 each have respectivesuture-contacting surfaces 30A, 32A which are contoured to promoteacoustic coupling between the first member 30 and the segment 16 ofmaterial to be joined, and to provide substantially continuous contactbetween at least the first suture-contacting surface 30A and at leastone of the segments to be welded. The size of the shear area of thefused portion 20, and thus the strength of the joint region, isdetermined by the length and width of the suture-contacting surfaces30A, 32A, the extent of contact between these surfaces and the segments16, 18, and particularly between the first surface 30A and the segment16 closest to the first surface, and the pressure exerted on thesegments by the first member 30 in the direction of arrow 35 duringwelding.

In addition to the geometries of the suture-contacting surfaces of thefirst and second members, the geometry of the material to be joined mustbe considered. Fused portions having the largest shear areas and thegreatest joint strengths can be obtained by configuring thesuture-contacting surfaces 30A, 32A of the first and second members tohave contours which correspond to the contours of the segments to bejoined so as to ensure maximum contact with the segment portions 16, 18.For example, if the material is a filament having a substantiallycircular cross-section, at least one of the suture-contacting surfacesshould preferably have a rounded contour to match the contour of thefilament in contact with it. If the material is a substantially flatribbon, at least one of the suture-contacting surfaces should preferablybe substantially flat to ensure maximum contact with the segment. If thematerial has a polygonal or elliptical cross-section, the contour of atleast one of the surfaces should preferably be grooved or channeled orotherwise shaped to correspond as closely as possible to the particularcontour of the material.

It is generally preferred to configure the ultrasonic welding tipmembers 30, 32 so that their respective suture-contacting surfaces 30A,32A engage the suture segment portions 16, 18 so as to provide a maximumshear area for the fused portion 20. Various geometries for thesuture-contacting surfaces 30A, 32A are illustrated in FIGS. 10A-14B.

As shown in FIGS. 10A and 10B, the suture-contacting surface 30A of thefirst member 30 is concave about the z and x axes, and thesuture-contacting surface 32A of the second member 32 is convex aboutthe z axis. The illustrated suture segments 16, 18 have a circularcross-section but need not be limited to a particular geometry. Contactbetween at least the first surface 30A and the top segment 16 issubstantially continuous over the entire length and width of the surface30A as a result of the contour of that surface. The shear area of theresulting fused portion 20 is relatively large, and thus the strength ofthe fused portion can be expected to be relatively high.

An advantage of incorporating a convex curvature to the secondsuture-contacting surface 32A is that the length of the joint region 14in the direction of the principal axis of the material can be reduced,thereby decreasing the diameter of the resulting fused loop of suturematerial.

As shown in FIGS. 10A and 10B, the radius of curvature of the convexsuture-contacting surface 32A is preferably equal to or smaller than theradius of curvature of the concave suture-contacting surface 30A. Inapparatus having a welding horn and anvil, both with a convexsuture-contacting surface, as in FIGS. 12A and 12B, the respective radiiof curvature of the convex surfaces can be either different orsubstantially the same, depending on the desired area of the fusedregion.

The suture-contacting surfaces 30A, 32A of the embodiment illustrated inFIGS. 14A and 14B have the same relationship to each other as in theembodiment of FIGS. 10A and 10B. The resulting fused portion 20 isrelatively large, with relatively high strength.

As shown in FIGS. 15A, 16 and 17A, the first suture-contacting surface30A of the first member 30 can have a channeled or grooved geometry toincrease the extent of contact between the first suture-contactingsurface 30A and the suture segment 16. As also indicated in FIGS. 15B,16 and 17B, the second member 32 may be comprised of multiple partswhich act to confine and maintain the alignment of the suture segments16, 18 during the welding process. The coupling portions of the secondmember separate after the welding process to release the joined materialfrom the confines of the welding apparatus without requiring the loop tobe moved or otherwise manipulated. FIGS. 15A, 15B and 16A illustrate onetype of ultrasonic welding apparatus, in which the second member 32couples together beneath the segments of material joined at the jointregion. The coupled members remain engaged during the welding process,as shown in FIGS. 15A and 16A, and separate after the welding process bya hinging or pivoting action to release the loop, as shown in FIG. 15B.

FIGS. 17A and 17B illustrate another type of apparatus, in which themultiple parts of the second member 32 slide away from each other torelease the joined loop. Other configurations for the second member 32which permit the loop to be released after the welding operation iscompleted are considered to be within the scope of the invention.

FIGS. 18, 19A and 19B illustrate still another configuration for thewelding apparatus, in which the suture segments 16, 18 to be welded areconfined and aligned or oriented relative to each other within the wallsof the second member 32. This apparatus produces welded joints having afused portion 20 in a vertical orientation instead of a horizontalorientation. In this apparatus, the first member 30 is complementarywith and fits inside two sections of the second member 32, which extendvertically on either side of the first member. The surfaces 30A, 32A ofthe first and second members are substantially flat, although they canbe cambered and contoured otherwise, as previously discussed. As shownin FIG. 19A, the overlapping portions 16, 18 of segment 12 of materialto be joined together are oriented in a diagonal alignment within themultiple parts of the second member 32. During the welding processultrasonic energy is delivered from a power supply and converted tomechanical energy to establish local frictional heating between thesegments 16, 18. Pressure is exerted on the segments 16, 18 in thedirection of arrow 35 as the segments are heated to a plastic state,causing portions of the segments to flow and to fuse in a verticallyoriented fused portion 20. Because the first and second members 30, 32are configured to confine and maintain the alignment of the overlappingsegments during the welding process, the joint region 14 and fusedportion 20 are relatively dense and compact, with little, if any, fusedmaterial disposed in regions outside of the fused portion 20. It isdesirable to minimize the extrusion of fused material beyond the fusedportion 20 so as to maximize the strength of the loop joint region andto avoid interference with, or irritation of, the surrounding tissue.

As in the above embodiments, the coupling portions of the second member32 can be separated after the welding process to release the joinedloop.

FIGS. 20-25 illustrate still other embodiments of the invention. InFIGS. 20 and 21, a fused region 20 of a fused loop is shown with atextured or waffled surface 34 imparted to the suture sections in thejoint region from corresponding textured or waffled suture-contactingsurfaces on the horn 30 and anvil 32. The waffled surface pattern on thesuture-contacting surfaces of the horn and anvil imparts a correspondingwaffled pattern on the respective suture sections when the horn andanvil compress the suture segments during a welding process. The waffledpattern increases the surface area of the suture sections in the jointregion, which may contribute to improved suture weld strength,particularly when the suture loop is under tension.

The surface patterns on the horn and anvil can be essentiallycomplementary, as shown in FIG. 23, or they can be non-complementary.The patterns in both types of surfaces may be etched, machined or coinedinto the material of the horn and anvil and can vary in either aperiodic or a non-periodic manner, to provide a desired pattern ortexture on the suture sections in the joint region. For example, onemight wish to emboss a company logo, serial number or other identifyingsymbol or code on the suture-contacting surfaces of the horn and anvilso that the resulting fused region of the suture sections includes thatidentifying mark.

As shown in FIGS. 24 and 25, the ability of the fused loop to stretch intension may be improved by imparting a waffled or otherwise texturedpattern to the suture sections in the joint region, thereby producing ajoint region which can be expanded or compressed in an accordionfashion. FIG. 24 illustrates a fused loop having such a joint region, inwhich the fused suture loop is in a relatively relaxed state and thejoint region is not under significant tension. When tension is appliedto the loop in the direction of arrows 38, as shown in FIG. 25, the loopwill stretch as the joint region expands in the direction of itsprincipal axis. This design may provide improved flexibility of thefused loop under tension and may contribute to improved strength of theloop. It also allows greater flexibility in the use of fused sutureloops, as a certain amount of built-in stretch will allow the loops toexpand if necessary rather than break if extended beyond a nominal loopdiameter.

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The presentembodiments are therefore to be considered in all respects asillustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range of theequivalency of the claims are therefore intended to be embraced therein.

1. (canceled)
 2. (canceled)
 3. (canceled)
 4. (canceled)
 5. (canceled) 6.(canceled)
 7. (canceled)
 8. (canceled)
 9. (canceled)
 10. (canceled) 11.(canceled)
 12. (canceled)
 13. (canceled)
 14. (canceled)
 15. (canceled)16. (canceled)
 17. (canceled)
 18. (canceled)
 19. (canceled) 20.(canceled)
 21. (canceled)
 22. (canceled)
 23. (canceled)
 24. (canceled)25. (canceled)
 26. (canceled)
 27. (canceled)
 28. (canceled) 29.(canceled)
 30. (canceled)
 31. (canceled)
 32. (canceled)
 33. (canceled)34. (canceled)
 35. (canceled)
 36. A fused loop of an elongated material,comprising: one or more segments of said material extending along aprincipal axis, portions of said segments being oppositely directed andjoined together to form a loop at a joint region extending between firstand second ends and including: i. a first portion of elongated materialextending from said first end, ii. a second portion of elongatedmaterial extending from said second end, and iii. a fused portionbetween said first and second portions, said fused portion comprising arelatively thin layer of fused material from the first and secondportions, wherein the elongated material in said first and secondportions of the joint region is characterized by a high degree ofmolecular orientation in the direction of the principal axis of thematerial and high strength in the direction of the principal axisrelative to the degree of molecular orientation and strength in otherthan the direction of the principal axis, and the fused material in thefused portion of the joint region is characterized by a low degree ofmolecular orientation in the direction of the principal axis of thematerial relative to the degree of molecular orientation in thedirection of the principal axis in said first and second portionsadjacent thereto, and the first and second portions at the first andsecond ends of the joint region outside of the fused portion havecross-sectional areas which are greater than the cross-sectional areasof the first and second portions of the joint region which abut thefused portion.
 37. A fused loop of an elongated material according toclaim 36, wherein the cross-sectional area of the first and secondportions at the first and second ends of the joint region and outside ofthe fused portion is approximately equal to the cross-sectional area ofa segment of the elongated material outside of the joint region.
 38. Afused loop of an elongated material according to claim 37, wherein thecross-sectional areas of said first and second portions of the jointregion abutting the fused portion are a minimum at approximately themiddle of the fused portion.
 39. A fused loop of an elongated materialaccording to claim 38, wherein the cross-sectional areas of said firstand second portions at approximately the middle of the fused portion areapproximately half the cross-sectional areas of the first and secondportions at the first and second ends of the joint region and outside ofthe fused portion.
 40. A fused loop of an elongated material accordingto claim 39, wherein a change in the cross-sectional areas of the firstand second portions per unit length of the first and second portions inthe direction of the principal axis of the elongated material issubstantially constant over the length of the fused portion.
 41. A fusedloop of an elongated material according to claim 40, wherein saidelongated material comprises a substantially monofilamentous material.42. A fused loop of an elongated material according to claim 41, whereinsaid monofilamentous material is a polymeric material.
 43. A fused loopof an elongated material according to claim 42, wherein saidmonofilamentous material is a thermoplastic material.
 44. A fused loopof an elongated material according to claim 43, wherein saidmonofilamentous material comprises a surgical suture material.
 45. Afused loop of an elongated material according to claim 40, wherein saidoppositely directed segments of said material are joined together in alap weld at said joint region.
 46. A fused loop of an elongated materialaccording to claim 45, wherein said weld is effected using ultrasonicenergy.
 47. A fused loop of an elongated material according to claim 45,wherein said weld is effected using laser energy.
 48. A fused loop of anelongated material according to claim 45, wherein said weld is effectedusing electrical arc discharge energy.
 49. A fused loop of an elongatedmaterial according to claim 45, wherein said weld is effected usingthermal energy.
 50. A fused loop of an elongated material according toclaim 40, wherein said loop is defined by joining oppositely directedportions of a single segment of said material.
 51. A fused loop of anelongated material according to claim 40, wherein said loop is definedby joining oppositely directed portions of a plurality of segments ofsaid material.
 52. A fused loop of an elongated material according toclaim 40, wherein upon application of a tensile force to said jointregion in the direction of the principal axis of the material so thatthe first and second portions of said joint region are loadedsubstantially in tension and the fused portion of said joint region isloaded substantially in shear, the following equation is substantiallysatisfied:A_(w)τ_(fw)≧A_(u)σ_(fu), wherein A_(w) is the shear area of the fusedportion, τ_(fw) is the shear stress to failure of the fused portion,A_(u) is the sum of the cross-sectional areas of the first and secondportions of the joint region near the first and second ends of the jointregion and outside of the fused portion, and σ_(fu) is the tensilestress to failure of the first and second portions of the joint regionnear the first and second ends of the joint region and outside of thefused portion.
 53. A fused loop of an elongated material according toclaim 41, wherein said segment of said elongated material comprises asingle strand of said substantially monofilamentous material.
 54. Afused loop of an elongated material according to claim 41, wherein saidsegment of said elongated material comprises a plurality of strands ofsaid substantially monofilamentous material.
 55. A fused loop of anelongated material according to claim 36, wherein said first portion,said second portion and said fused portion bear a pattern transverse tothe principal axes of said elongated material adjacent to the respectivefirst and second portions.
 56. A fused loop of an elongated materialaccording to claim 55 wherein the respective imparted patterns of saidfirst portion and said second portion are complementary.
 57. A fusedloop of an elongated material according to claim 55 wherein therespective imparted patterns of said first portion and said secondportion are non-complementary.
 58. A fused loop of an elongated materialaccording to claim 55 wherein the imparted pattern of at least one ofsaid first and second portions is periodic.
 59. A fused loop of anelongated material according to claim 55 wherein the imparted pattern ofat least one of said first and second portions is aperiodic.